Comparing two surgical techniques for treating cervical cancer
Official title: A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer
Run by Peking Union Medical College Hospital · NCT06836869 · Data updated 2026-11-12
This study is testing whether a new type of minimally invasive surgery for cervical cancer works better and has fewer complications than the traditional surgery for patients with early-stage disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 524 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 17 sites (Lanzhou, Gansu and 16 other locations) |
| Status | Recruiting |
| Started | February 20, 2025 |
| Main results expected | July 2032 |
| Study ends | July 2032 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT06836869 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are females aged 18 to 65 with histologically confirmed FIGO stage IB2 cervical cancer.
✕Probably not a fit
Patients with special pathological types of cervical cancer or those who do not meet the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) compared to traditional abdominal radical hysterectomy (ARH) for patients with FIGO stage IB2 cervical cancer. Participants will be randomly assigned to undergo either LRH-MTF or ARH and will be monitored for disease-free survival rates and complications over a period of 4.5 years post-operation. The study also includes follow-up assessments and quality-of-life questionnaires to gather comprehensive data on patient outcomes.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option for patients with cervical cancer, potentially leading to improved recovery and quality of life.
How similar studies have gone: Other studies have shown promising results with laparoscopic techniques in various cancers, suggesting potential success for this approach, although this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
1. Inclusion Criteria: 1.1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 1.3 FIGO 2018 stage IB2. 1.4 The maximum diameter of the cervical lesion measured by MRI is \>2 cm and ≤4 cm. For those with MRI contraindications, PET/CT, CT, or ultrasound can be used as alternatives. 1.5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 1.7 Willing to participate in this trial and sign the informed consent form. 1.8 Able to cooperate and complete follow - up and relevant examinations. 1.9 For pre - menopausal women, a negative pregnancy test within 30 days before surgery. 1.10 Laboratory test indicators of vital organs meet the standards 2. Exclusion Criteria: 2.1 Special pathological types (gastric - type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma, etc.). 2.2 Imaging examinations suggest pelvic or para - aortic lymph node metastasis (MRI or CT shows a short - axis diameter of ≥1.5 cm, or SUV ≥2.5), or histopathology indicates lymph node metastasis. 2.3 History of pelvic and abdominal radiotherapy. 2.4 History of neoadjuvant chemotherapy. 2.5 Uterus larger than that at 10 weeks of pregnancy. 2.6 Contraindications for surgery and anesthesia (such as severe medical comorbidities). 2.7 Patients who cannot tolerate the Trendelenburg position. 2.8 Patients who cannot cooperate with treatment and follow - up. 2.9 Pregnant patients. 2.10 History of other malignancies, except for those who have been cancer - free for more than 3 years with no current evidence of tumor recurrence.
Where it's running
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting -
Cangzhou Central Hospital
Cangzhou, Hebei, China Recruiting -
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Recruiting -
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China Recruiting -
The Second Hospital of Jilin University
Changchun, Jilin, China Recruiting -
Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, Shanghai Municipality, China Recruiting
Show 11 more locations
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Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
Xianyang, Shanxi, China Recruiting -
The Fourth Military Medical University, Xijing Hospital
Xi’an, Shanxi, China Recruiting -
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China Recruiting -
Zhejiang cancer hospital
Hangzhou, Zhejiang, China Recruiting -
Peking Union Medical College Hospital
Beijing, China Recruiting -
Sichuan Cancer Hospital and Institute
Chengdu, China Recruiting -
Southwest Hospital
Chongqing, China Recruiting -
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China Recruiting -
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, China Recruiting -
Tongji Medical College
Wuhan, China Recruiting -
The First Hospital of Lanzhou University
Lanzhou, Gansu, China Not yet recruiting
Study contacts
- Study coordinator: Yuan Li, professor
- Email: liyuan10833@pumch.cn
- Phone: +8617810376318
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.